Quantitative analysis of Cefpodoxime Proxetil raw material and dry suspension using proton nuclear magnetic resonance

作     者：Yufei Liu Bin Li Xinyu Tao Dongyang Zhao Xinyu Zhang Yan Wu Wenyi He Chenggen Zhu Xiangju Jin Hongyue Liu Xin Di Ye Tian Yanan Wang 

作者机构：State Key Laboratory of Bioactive Substance and Function of Natural MedicinesInstitute of Material MedicaChinese Academy of Medical Sciences&Peking Union Medical CollegeBeijing 100050China Division of antibioticsNational Institutes for Food and Drug ControlBeijing 100050China School of pharmacyShenyang Pharmaceutical UniversityShenyang 110016China School of pharmacyBeihua UniversityJilin 132013China 

出 版 物：《Asian Journal of Traditional Medicines》 (亚洲传统医药（英文）)

年 卷 期：2024年第19卷第6期

页      面：305-320页

学科分类：07[理学] 070202[理学-粒子物理与原子核物理] 0702[理学-物理学] 

基　　金：funded by the National Key R&D Program of China(2022YFE0199700) 

主　　题：qNMR qGSD cefpodoxime proxetil uncertainty HPLC-SPE-NMR 

摘      要：This study established a simple,rapid,and accurate nuclear magnetic resonance(NMR)quantitative method to determine the cefpodoxime proxetil content in raw materials and dry suspensions,and evaluated the *** relative content of cefpodoxime proxetil iso-A and iso-B was also analyzed based on 1H *** this study,an internal standard method was used,with DMSO-d6 as the solvent and maleic acid and 1,3,5-trimethylbenzene as internal standards,to calculate the concentration of the *** analysis was performed using both the traditional quantitative NMR(traditional qNMR)and the quantitative Global Spectral Deconvolution(qGSD)*** linearity range,quantitation limit,precision,robustness,and accuracy of these quantitative analysis methods were *** results indicated that both internal standards and integration methods met the requirements of the“9101 Guidelines for Analytical Method Validationin the 2020 edition of the Chinese *** to the traditional qNMR,qGSD has unique advantages in accurate quantitative analysis in complex *** using the combined HPLC-SPE-NMR technique,cefpodoxime proxetil iso-A and iso-B were enriched and analyzed,and their NMR data were accurately *** quantitative analysis results were in line with the requirements of the Chinese Pharmacopoeia.